# Cooltouch Corp.

- Location (FDA's records): Roseville, CA
- FDA decisions: 6 (2000–2006): 6 510(k) clearances
- Names in FDA's records: Cooltouch Corp. (4); Cooltouch, Inc. (2)
- Product codes: GEX (6)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 13 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Diomed, Inc.: 2 (https://510kreport.com/company/diomed)
- Biolitec, Inc.: 2 (https://510kreport.com/company/biolitec)
- New Star Lasers, Inc.: 1 (https://510kreport.com/company/new-star-lasers)

## Firms that cite its devices most
- Sciton, Inc: 4 (https://510kreport.com/company/sciton)
- Altus Medical, Inc.: 2 (https://510kreport.com/company/altus-medical)
- Innotech USA, Inc.: 1 (https://510kreport.com/company/innotech-usa)
- Candela Corp.: 1 (https://510kreport.com/company/candela)
- Industrial & Medical Design, Inc.: 1 (https://510kreport.com/company/industrial-medical-design)
- Biolitec, Inc.: 1 (https://510kreport.com/company/biolitec)
- Quantel Medical: 1 (https://510kreport.com/company/quantel-medical)
- AngioDynamics, Inc.: 1 (https://510kreport.com/company/angiodynamics)

## Its most-cited devices
- K003715: Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model Cooltouch, Cooltouch II (2001), cited by 6
- K014035: Cooltouch and Cooltouch-II ND:Yag Laser Systems (2002), cited by 4
- K040921: Cooltouch, Model NS 160 (2004), cited by 2
- K010316: Cooltouch Varia ND:Yag Laser System; Cooltouch Varia-II ND:Yag Laser System (2001), cited by 1

## Recent decisions
- K060966: Cooltouch Varia ND:Yag Laser System (Jul 31, 2006)
- K040921: Cooltouch, Model NS 160 (Sep 28, 2004)
- K014035: Cooltouch and Cooltouch-II ND:Yag Laser Systems (Mar 7, 2002)
- K010316: Cooltouch Varia ND:Yag Laser System; Cooltouch Varia-II ND:Yag Laser System (May 1, 2001)
- K003715: Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model Cooltouch, Cooltouch II (Mar 1, 2001)
- K003781: Cooltouch Varia-II ND:Yag Laser System (Dec 20, 2000)

Source page: https://510kreport.com/company/cooltouch